The Acute Effects of Chamomile Intake on Blood Coagulation Tests in Healthy Volunteers

Chamomile may possess anticoagulant effects based on the presence of coumarin-like compounds within the flower. This randomized complete crossover study will investigate the impact of chamomile ingestion acutely on coagulation.

Study Overview

• Status: Completed
• Conditions: Coagulation Disorder
• Intervention / Treatment: Dietary supplement: Chamomile Tea; Dietary supplement: Chamomile Extract Capsule

Detailed Description

Subjects will be enrolled into two groups in a crossover fashion upon obtaining written informed consent. The two intervention groups include (1) chamomile tea intake and (2) chamomile extract intake. Subjects will consume a single preparation of chamomile tea or extract capsule, and partake in a minimum of three days washout period between interventions. Screening assays of coagulation will be obtained immediately before the ingestion of chamomile, two hours after ingestion, and four hours after ingestion over the course of a single day.

• Study Type: Interventional
• Enrollment (Actual): 8
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • New York
    • Stony Brook, New York, United States, 11794
      • Stony Brook University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Able to provide informed written consent
• Able to withhold use of other chamomile products (teas, lotions, supplements, extracts); will only use study-supplied chamomile products for duration of study
• Able to withhold intake of solid food at least 6 hours before intake of the chamomile preparation
• Able to withhold intake of clear liquids at least 2 hours before intake of the chamomile preparation

Exclusion Criteria:

• Past medical/family history of bleeding/thrombotic disorders (e.g. hemophilia, von-Willebrand disease)
• Chronic medications known to affect hemostasis (anticoagulants, antiplatelet agents, SSRIs, herbal/complementary medicine agents)
• Three or more alcoholic drinks daily
• Sedentary status/ restricted mobility
• Active smoker or quit smoking within one week of study period
• Females who are pregnant, breast-feeding, or lactating
• History of estrogen-dependent condition such as uterine fibroids, breast cancer, uterine cancer, or ovarian cancer
• Scheduled surgical procedure during study period
• Hospitalized patients
• Underweight (BMI < 18 kg/m2) or history of malnourishment
• Active symptoms of a respiratory, dermatologic, urinary, or gastrointestinal infection
• Diagnosed allergy to chamomile
• Severe allergy to ragweed
• Physical inability to consume chamomile tea according to the study dosing schedule
• Prescription usage of an anticoagulant agent such as warfarin, anti-Xa inhibitor, or other novel oral anticoagulants
• ADP antagonist use, including clopidogrel, prasugrel, and ticagrelor
• GPIIb/IIIa inhibitor use, including ticlopidine, eptifibatide
• More than weekly NSAID use (e.g. aspirin, ibuprofen, naproxen)
• Diagnosis of a bleeding-diathesis disorder
• Diagnosis of a hypercoagulable state
• History of elevated INR or other abnormal bleeding study (PT, aPTT, thrombin time, reptilase time, above the upper limit of normal for Stony Brook Hospital Reference Range) while not taking anticoagulants or herbal supplements listed below

• Active intake of the following herbal supplements at time of study enrollment that may alter baseline coagulation function including:

  • Ginger
  • Garlic
  • Gingko
  • Ginseng
  • Fish oil
  • Black Cohosh
  • Feverfew
  • Valerian
  • Coenzyme Q10
  • Goldenseal
  • St. John Wort
• Active intake of chamomile extracts or teas at time of study enrollment
• Inability to discontinue the aforementioned herbal supplements more than 14 days before enrollment into the study
• Significant fear of needles or fainting blood draws
• Actively taking cyclosporine
• Patient refusal to participate in study for the allotted study period

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Screening
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Chamomile Tea; Subjects will consume a single serving of chamomile tea on the visit day. The tea serving will be prepared using 3 grams of chamomile tea steeped in hot water according to the study protocol.	Dietary supplement: Chamomile Tea; Chamomile tea bags consumed by subjects as described in study arms section.
Experimental: Chamomile Extract Capsule; Subjects will consume a single chamomile capsule on the visit day. Each capsule consists of 500 milligrams of a chamomile extract that has been standardized to 1.2% apigenin content.	Dietary supplement: Chamomile Extract Capsule; Chamomile extract capsules consumed by subjects as described in "Experimental: Chamomile Extract Capsule" study arms section.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Change in Prothrombin Time	At two hours and four hours after the intervention

Secondary Outcome Measures

Outcome Measure	Time Frame
Change in Activated Partial Thromboplastin Time	At two hours and four hours after the intervention
Change in Thrombin Time	At two hours and four hours after the intervention
Change in Reptilase Time	At two hours and four hours after the intervention

Collaborators and Investigators

• Sponsor: Stony Brook University

Study record dates

Study Major Dates

• Study Start (Actual): March 16, 2022
• Primary Completion (Actual): May 12, 2022
• Study Completion (Actual): May 12, 2022

Study Registration Dates

• First Submitted: February 27, 2022
• First Submitted That Met QC Criteria: March 8, 2022
• First Posted (Actual): March 9, 2022

Study Record Updates

• Last Update Posted (Actual): June 10, 2022
• Last Update Submitted That Met QC Criteria: June 8, 2022
• Last Verified: June 1, 2022

More Information

Terms related to this study

• Keywords: Coagulation; Chamomile
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Hematologic Diseases; Hemorrhagic Disorders; Hemostatic Disorders; Blood Coagulation Disorders
• Other Study ID Numbers: IRB2022-00036

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No